URIDINE POWDER,ORAL
Clinical Criteria Summary
Inclusion Criteria
- Patient exhibits severe or life-threatening toxicity within 96 hours following the end of fluorouracil continuous IV infusion (CIVI) or capecitabine administration.
- An overdose of fluorouracil CIVI or capecitabine is suspected, regardless of the presence of symptoms.
Exclusion Criteria
- Time from end of fluorouracil infusion or last capecitabine dose is greater than 4 days (96 hours).
Dosing & Administration
- Premedication: Ondansetron 8 mg orally, given 20 minutes prior to each uridine dose.
- Dosage: 10 grams (1 packet) orally every 6 hours for 20 doses (full course), without regard to meals. Do not chew.
- Oral Administration: Mix each packet of granules with 3-4 ounces of soft foods (e.g., applesauce, pudding, yogurt) and ingest within 30 minutes. Drink at least 4 ounces of water. Do not chew the granules.
- Vomiting Management: If patient vomits within 2 hours of a dose, initiate another complete dose as soon as possible after vomiting episode. Administer next dose at regularly scheduled time.
- Missed Dose Management: Administer dose as soon as possible. Give next dose at regularly scheduled time.
- NG/G-Tube Administration: Prepare about 4 ounces (100 ml) of a food starch-based thickening product in water and stir until dissolved. Crush contents of a 10 gram packet to a fine powder. Add crushed granules to prepared thickening product and mix thoroughly. After administration, flush tube with water.
Supportive Care & Management
- While awaiting antidote: Admit patient to inpatient unit and provide supportive care to reduce symptom severity (e.g., IV hydration, electrolyte replacement, treatment of diarrhea, mouth/skin care, granulocyte colony-stimulating factor administration, continuous cardiac monitoring).
- Avoid contraindicated medications that might interfere with clearance of fluorouracil or capecitabine (e.g., metronidazole, leucovorin, cimetidine, thiazide diuretics).
- Continue close monitoring post-hospitalization for possibly delayed adverse effects, particularly throughout the expected neutrophil nadir. Granulocyte colony-stimulating factors and antibiotics may need to be continued.
Clinical Considerations & Definitions
- Uridine triacetate is NOT to be used to minimize non-emergent/non-life-threatening toxicity of fluorouracil or capecitabine, as use in this manner may diminish the efficacy of these drugs.
- Examples of early onset fluoropyrimidine toxicities include: Gastrointestinal (oral mucositis, diarrhea, anorexia), Cardiac (arrhythmia, chest pain, cardiac arrest), Hematologic (neutropenia, thrombocytopenia), Dermatologic (erythema, desquamation), and Neurologic/CNS (altered mental status, seizures, confusion).
- Overdose definition: Patient receives 10% more than intended dose (>110% of planned dose) or received full dose at an infusion rate 25% more than intended rate.